510(k) K792680
K792680 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "BLASTOMYCES DERMATITIDIS, ANTIGEN". The FDA issued a decision of Substantially Equivalent on January 17, 1980. The device falls under product code JWW (Antigen, Cf, B. Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1980
- Date Received
- December 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, B. Dermatitidis
- Device Class
- Class II
- Regulation Number
- 866.3060
- Review Panel
- MI
- Submission Type